Federal report on stent procedures finds potential fraud

Tricia Bishop, The Baltimore Sun

While Dr. Mark Midei was allegedly implanting unnecessary cardiac stents in hundreds of patients at a Towson hospital, stent manufacturer Abbott Laboratories was paying for crab and barbecue feasts at his Monkton home and building a business strategy around the Maryland cardiologist's high output, according to a federal report being released today.

Abbott, a $30 billion-a-year, Chicago-based pharmaceutical firm, ranked Midei among its top-volume doctors in the Northeast and made plying him with research money and "VIP trips" part of its business plan in late 2008 — about the time Midei's usage of Abbott-brand stents soared, the report said.

The 170-page document contains the findings of a months-long investigation by the U.S. Senate Committee on Finance into allegations of inappropriate and potentially harmful cardiac procedures performed by Midei at St. Joseph Medical Center. It calls the case "a clear example of potential fraud, waste and abuse," noting that St. Joseph billed government and private insurers more than $6.6 million for the procedures.

Committee Chairman Sen. Max Baucus also raised concerns in a statement that "this could be a sign of a larger national trend of wasteful medical device use." Similar allegations have been made against cardiologists in at least three other states and elsewhere in Maryland.

"Hospital patients expect their care to be based on medical need, not profits," the Montana Democrat said. "This report sets forth alarming evidence that patients at St. Joseph's Medical Center received unnecessary and potentially harmful stent implants time and again — a pattern that is shocking, disturbing and shameful.

"Doctors should not be performing invasive medical procedures patients don't need, and taxpayers certainly shouldn't be paying for these wasteful and improper implantations."

The Senate report includes dozens of e-mails, letters and other documents, subpoenaed by the committee, that reveal a cozy and sometimes lucrative relationship between Midei, St. Joseph and Abbott. In one exchange, Abbott officials congratulated Midei for implanting 30 stents in one day, calling it a record and describing the physician as "one of the highest implantors [sic] thus far."

Investigators for the Senate Finance Committee, which has long been concerned about inappropriate relationships between pharmaceutical companies and physicians, said their investigation raises questions about "whether or not Abbott Laboratories indirectly encouraged Dr. Midei to intensify his use of stents, with unfortunate results."

Abbott declined to answer questions Friday, but issued a statement saying, "Dr. Midei has been a highly regarded physician in his field, with whom Abbott had consulted in the past. Our affiliation with Dr. Midei ended early this year."

St. Joseph said it had not seen the report and declined to answer questions Friday, while Midei's attorney, Stephen L. Snyder, dismissed it, saying simply: "Big deal."

Among other details in the Senate report:

• Abbott paid for social events at Midei's home, including a "beers and crabs" dinner and a whole-pig barbeque for employees of the St. Joseph cardiac lab. A company official also lauded an Abbott saleswoman for her business relationship with Midei, calling it the strongest the official has seen in 15 years.

• Abbott officials enlisted Midei as a paid consultant after he was forced out of St. Joseph, calling it the right thing to do because "he helped us so many times over the years." The company paid him more than $30,000 to market its "Xience V" stent in Japan, after the media climate in the United States became "too hot."

• The company noted an "ugly" decline in the volume of stent procedures at hospitals throughout the Baltimore region after the allegations against Midei became public, including a 46 percent drop at St. Joseph.

• One Abbott official suggested that local connections or the "Philly mob" should intervene to silence Baltimore Sun columnist Jay Hancock for his coverage of the scandal, saying "someone needs to take this writer outside and kick his ass!"

The report does not offer recommendations or outline a next step, though some safety measures have already been added through recent legislation, Baucus said.

"Aggressive new tools, like improved screening of medical providers and increased oversight, [were included] in the new health care reform law to root out fraud, waste and abuse like this," Baucus said.

The U.S. Senate committee, which oversees the taxpayer-funded Medicare and Medicaid programs, launched the investigation in February after a story in The Sun about Midei's questionable procedures. The inquiry focused on Midei, St. Joseph and Abbott, which manufactures the stents that Midei typically used during his last year of work at the hospital, which ended in May 2009.

Investigators reviewed roughly 10,000 documents to uncover the relationship between Midei and Abbott, as well as an industry culture that seems to encourage the use of expensive stents.

The devices, which can prop open a clogged artery to clear blockage, take less than half an hour to put in place and typically cost about $12,000 apiece, which is often paid by taxpayers.

Medicare spent $25.7 billion nationwide on stents over a five-year period, according to the Senate report. And the government-funded program paid more than half — $3.8 million — of the amount that St. Joseph billed insurers for hundreds of questionable stents implanted by Midei. The hospital last month agreed to repay the federal funds.

Beyond the financial costs, the Senate committee also focused on the health costs of unnecessary procedures. Stent recipients face an increased risk of blood clots, which can lead to death, and patients have to take blood thinners that carry other risks.

A previously undisclosed St. Joseph report, obtained by the committee, concluded that Midei's "practice of placing stents in patients where not clinically indicated resulted in the substantial likelihood of harm to his patients" by exposing them "to the potential for serious complication."

Midei, who earned more than $1 million in annual salary at St. Joseph, was among the Towson hospital's most prominent physicians, well-respected in the field of interventional cardiology. He is accused of placing stents in hundreds of people whose medical records suggest that they didn't need them, and faces potentially hundreds of civil lawsuits based on the allegations.

Midei stands by his medical decisions, however, and has long said he did nothing improper. He filed a $60 million lawsuit against St. Joseph in October, accusing the hospital of fraudulently ruining his reputation.

"The Senate is speculating, as is everybody else. There's no news here," said Snyder, Midei's attorney, adding that he expects his client to be exonerated.

"Those allegations have been out there for a long time, and it doesn't seem like [the report] adds anything," Snyder said. "The verdict's not in yet."

The first complaint against Midei came anonymously in November 2008 to the Maryland State Board of Physicians, which licenses and disciplines doctors. But St. Joseph was not informed and the board didn't intervene, so Midei continued to practice for another six months, placing questionable stents in nearly 200 more people during that time, according to hospital records contained in the Senate report.

Midei lost his privileges to practice at St. Joseph after the hospital conducted its own investigation in mid-2009, and he has since resigned. The Physicians Board filed professional charges against him in June; an administrative hearing is scheduled for Dec. 14.

It's unlikely the hospital could have uncovered wrongdoing on its own, the Senate Finance Committee and others found. St. Joseph's internal "peer review" system allowed Midei, as the chairman of the cardiology department, to select cases for evaluation. The hospital has since revamped and randomized its self-policing programs.

After concerns were raised, St. Joseph hired reviewers to look at 1,878 of Midei's stent cases going back to 2007 and identified 585 cases where medical records did not appear to support implanted stents. The hospital limited the look back to two years because the risk of related complications drops after then, though lawyers and at least one physician have criticized the time-dependent analysis, saying anyone stented improperly at any time has a right to know.

"Dr. Midei may have been stenting normal or minimally narrowed coronary arteries before 2007," Dr. William Boden, chief of cardiology at the Buffalo General and Millard Fillmore hospitals in New York, told Senate investigators. "It's like the rationale of SJMC is that, since complications were likely to be low prior to 2007, let's not go looking for trouble. It's not sound logic."

The Senate Finance Committee, having spent the past six years studying the financial links between doctors and drug or device makers and their influence on medical decisions, focused its gaze largely on the relationship between Abbott and Midei.

Consumer advocates have raised concerns that gifts or payments by companies to physicians are really thin veils for illegal kickbacks, which has led to a call for more transparency in the industry.

Beginning in 2012, companies have to record anything given to physicians worth more than $10 — including food, entertainment and consulting fees — and report the payments to a public database in 2013.

Pharmaceutical and medical technology organizations provide guidelines for gift-giving and compensation, as do many individual hospitals. Massachusetts and Vermont also have laws limiting exchanges, though Maryland does not, according to health care lawyers.

In 2007, as stent use in the United States started to decline amid evidence that less invasive treatments with drugs could be equally effective, Abbott was planning a strategy to market the Xience V stent, which had not yet been approved for use by the Food and Drug Administration.

The company's Medical Advisory Board suggested it "improve relationships with the cardiology community."

The company had identified Midei as a top-volume stent doctor, performing about 1,000 procedures per year, and turned to him as a stent ambassador, Senate committee records show. He debated a Hopkins doctor about stent use at an event sponsored by Abbott at Ruth's Chris Steak House, and is listed as a "decision maker" on internal Xience V documents labeled "Project Victory."

The FDA approved the Xience V, which is coated with drugs to help prevent scar tissue from forming around it after it is implanted, in July 2008. The approval came a few weeks before an Abbott employee paid nearly $700 for a "beers and crabs" dinner at Midei's 7,000-square-foot home, which is set on 30 acres of rolling pasture in Monkton.

Soon, the Xience V was the only drug-eluting stent Midei used, according to St. Joseph records on his stent usage from 2006 through mid 2009.

Snyder says there is a simple explanation: "It's the market leader, and he was getting the best results with it," he said.

In a statement, Abbott said that the Xience stent "is the most widely used drug eluting stent based on multiple clinical trials showing its superiority in safety and efficacy to the previous market leading drug eluting stent. Cardiologists around the world use Xience in their practices given its superior data and patient benefits."

On a single Friday in late August — a few days before Abbott pitched in $1,200 for a barbecue at his home — Midei placed 30 Xience stents in patients, earning this congratulatory note from Abbott's executive vice president of medical devices:

"I heard thru the grapevine that you had a truly outstanding day with Xience in the labs on Friday, perhaps setting the single day implant record," John M. Capek wrote, adding "stay in touch, and thanks for your support."

Midei's career at St. Joseph was over less than a year later, but Abbott stayed loyal for a time, making plans to send him to Asia in January of this year so Midei could give a Xience V safety presentation and market the device.

"In order to maximize our investment in Mark over the next 2 1/2 months, we'll need everyone's help," Chief Medical Officer Chuck Simonton wrote in an e-mail to staff.

After the allegations against Midei became public, however, the company decided against employing him in the U.S., to avoid bad publicity. "The press is just too hot," an Abbott executive wrote to Simonton on Jan. 15 of this year, the same day The Sun published an article about the allegations that Abbott circulated among executives.

A week later, Sun Business columnist Jay Hancock wrote a piece that raised questions about whether stents are often "overused and in some instances abused."

The column prompted David C. Pacitti, Abbott's vice president of global marketing, to send a message to another Abbott official saying: "Don't you have connections in Baltimore????? Someone needs to take this writer outside and kick his ass! Do I need to send the Philly mob?"

Midei's Japan trip was soon cut short.

"Mark understands the sensitivities and is returning to Baltimore today," Simonton said in a message Jan. 24. Later, he said the company could continue to work with Midei "behind the scenes" in the U.S., but not publicly. It appears the relationship ended soon after.

Midei later worked at the Prince Salman Heart Center in Saudi Arabia, according to an e-mail he sent Abbott executives in April, but that ended after the center found out about the allegations, his lawyer said.

He's not working at all now, his lawyer said. The Senate committee, meanwhile, plans to keep exploring questions about stent use in the United States, according to investigators.

"The Committee will continue to monitor issues relevant to improper use of cardiac stents and medical device procedures," the report said, "and perhaps most importantly the mechanisms in place to identify such situations at the earliest possible time."

January 2008: Dr. Mark Midei leaves MidAtlantic Cardiovascular Associates to become a full-time employee of St. Joseph Medical Center.

June 3, 2008: St. Joseph, MidAtlantic and MedStar's Union Memorial Hospital receive subpoenas from the U.S. Department of Justice and the Office of the Inspector General within U.S. Department of Health and Human Services.

Nov. 10, 2008: The Maryland Board of Physicians receives the first of two anonymous complaints from a self-professed SJMC employee alleging medical fraud by Midei.

April 27, 2009: One of Midei's patients, who also worked at St. Joseph, told hospital staff that he had concerns about his treatment. Federal investigators inquired about Midei's high stent rate at about the same time.

May 12, 2009: St. Joseph relieves Midei from duty after performing an internal review of his work.

July 2009: St. Joseph claims to have reached agreement with the federal government to settle any potential claims related to its dealings with MidAtlantic. The hospital also revokes Midei's practice privileges.

November 2009: St. Joseph begins sending letters to roughly 600 of Midei's patients telling them they might have had unneeded stents implanted in their coronary arteries and suggesting they see a doctor.

February 2010: Del. Peter A. Hammen asks the state health department to initiate a review of what happened at St. Joseph and to investigate whether unnecessary invasive procedures are taking place at other hospitals in Maryland. The U.S. Senate Finance Committee, which oversees Medicare and Medicaid programs, also opens an investigation in search of fraud.

May 2010: State regulatory documents indicate that Midei was able to avoid St. Joseph's peer review process because, as a department head, he chose which cases would be reviewed.

June 2010: State regulators reviewing billing records determine that other doctors in Maryland have suspiciously high rates of placing stents. The regulatory board responsible for licensing doctors in Maryland files administrative charges against Midei, beginning a process that could strip him of the authority to practice medicine in the state.

Sept. 1, 2010: Salisbury cardiologist John R. McLean is indicted on charges of health care fraud in connection with the alleged placement of unneeded coronary stents in hundreds of patients.

Sept. 21, 2010: The health agency committee investigating unnecessary procedures in Maryland submits its findings to the legislature, showing that current regulatory efforts are incapable of preventing fraud and unnecessary medical procedures.

Oct. 22, 2010: Midei files a $60 million lawsuit against St. Joseph alleging that it made him into a "sacrificial lamb" to deflect the attention of civil investigators looking into a separate, kickback scheme.

Nov. 10, 2010: St. Joseph agrees to a $22 million fine to settle kickback claims and repay Medicare funds received for questionable stents placed by Midei.